Instrumentation & Metrology Specialist III

NCBiotech; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Stock Options

401k with 4% Match

Medical, Vision and Dental

Disability Insurance

Life Insurance

23 Days PTO

Holidays and Floating Holidays

Paid Parental Leave

Job summary

Humacyte Inc in Durham, NC seeks an Instrumentation and Metrology Specialist III to provide metrology, instrumentation and controls expertise across manufacturing, utility and lab equipment on-site. Primary duties involve instrument calibration, equipment controls support, and collaboration with maintenance and QA teams.

The ideal candidate has advanced knowledge of GMP equipment instrumentation, willingness to assist with general maintenance, and the ability to work across departments on

Qualifications

• Degree in Engineering, Life Sciences or related field, or equivalent training.
• 7 years of metrology, instrumentation or calibration experience.
• 7 years of Quality System/Pharmaceutical experience preferred.
• ISA-CCST or equivalent preferred.
• NFPA-70E electrical safety training preferred.
• Clean room gowning and PPE compliance required.

Responsibilities

• Ensure GMP/GLP compliance for equipment maintenance.
• Lead calibration and preventive maintenance on GMP and non-GMP equipment.
• Draft calibration procedures and work instructions for process and utility equipment.
• Recommend instrumentation/metrology spare parts and PM plans.
• Troubleshoot, test, repair and optimize instruments and control systems.
• Collaborate with departments for continuous improvement of site maintenance.
• Oversee calibration standards and vendor calibration documentation.
• Coordinate with contract service providers for calibration and metrology activities.

Skills

Instrumentation calibration

Electrical safety NFPA-70E

Process control loops

GMP/GLP instrumentation knowledge

Education

Bachelor's degree in Engineering/Life Sciences or related field

Job description

DEPARTMENT: Site Operations

LOCATION: Durham, NC; Onsite/Not Remote

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com.

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JOB SUMMARY:

The Instrumentation and Metrology Specialist III will provide metrology, instrumentation and controls knowledge and expertise for manufacturing, utility and laboratory equipment throughout the Humacyte site. Though the primary duties of this position will center on instrument calibration and equipment controls support, the position may be required to collaborate and/or assist with the general equipment and facilities maintenance group. The ideal candidate will display an advanced knowledge of GMP equipment instrumentation and controls, willingness and expertise to assist with general maintenance, and the ability to collaborate with other departments as needed.

ESSENTIAL FUNCTIONS:

• Partner with Quality, Engineering and Operations groups to ensure strict compliance with GMP / GLP guidelines at all times, specifically to ensure that the equipment is maintained in GMP / GLP requirements.
• Leads, maintains, and performs basic and advance corrective, preventative maintenance calibration on GMP and non-GMP equipment and instruments.
• Drafts all calibration procedures needed and assists in the drafting of work instructions for all process and utility equipment.
• Research and provides informed recommendations for instrumentation/metrology spare parts and PM job plans.
• Assists in routing all required documentation for the submittal of spare parts and PM WOS.
• Site Subject Matter Expert to troubleshoot, test, repair and optimize instruments, equipment and control systems.
• Provides I&C expertise and guidance in the Capital design, appropriation, and installation processes.
• Collaborate with all departments in the continuous improvement efforts within the site maintenance program.
• Oversees and assists in the maintenance and review of calibration standards and vendor calibration documentation.
• Works with contract service providers and support contractor executing calibration, controls and metrology activities.
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Degree in Engineering, Life Sciences or other related technical field, or equivalent military training preferred.
• 7 years of applicable Metrology, Instrumentation or Calibration experience required.
• 7 years of Quality System / Pharmaceutical experience is preferred.
• Instrumentation Technical Training Certificate (ISA-CCST) or equivalent preferred.
• Trained in electrical safety NFPA-70E (144 hours of formal instruction on electrical safety, electrical systems, electronics) preferred.
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.
• Will be required to regularly to sit; stand for prolonged periods of time. Also, may occasionally be required to pull, lift and/or move up to 20 pounds.
• Position may require working holidays, weekends and overtime.

SPECIFIC SKILLS:

• Advance understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities and laboratory environments.
• Proven knowledge and understanding of electrical panels and electrical safety procedures.
• Advance understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios.
• Skilled with pneumatic, mechanical and electrical instrumentation; as well as manual and computer-based process control loops and systems; understands and applies basic concepts of calibration and requirements including accuracy testing. Advance understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments.
• General electrical panel knowledge and electrical safety procedures.
• Able to make independent decisions within defined scope of work, seeks clarification and directions when needed. Must be self-driven and demonstrate ability to work with little direction.

COMPENSATION & BENEFITS HIGHLIGHTS:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.